# K000697: Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits

- Pathway: 510(k) (Special)
- Applicant: Allegiance Healthcare Corp.
- Decided: Mar 30, 2000 after 29 days
- Product code: BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer)
- Device class: 2
- Regulation: 21 CFR 868.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
119 later devices descend from it; 7 cite it directly.
21 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020332: Respiratory Humidifier, Model MR850 (2003), 65 descendants of its own
- K033710: MR850 Respiratory Humidifier, Model MR850JHU (2004), 54 descendants of its own
- K073706: Respiratory Humidifier, Model MR850 (2008), 47 descendants of its own
- K040790: Modification to LTV 1000 Ventilator/Breathing Circuits (2004), 44 descendants of its own
- K092846: Airvo Series Humidifiers (2010), 30 descendants of its own

Source page: https://510kreport.com/device/K000697
Methodology: https://510kreport.com/methodology